Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects

NCT01701505 | Completed Phase 2 Results

• 1 other identifier: SR 2-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

Conditions

Anesthesia

Keywords

operative; dental procedure

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.

  If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

  at 14 minutes with a 3 minute window

Secondary Outcomes (7)

• Naris Examination (NE) to Assess Reactions to the Study Drug.

  At Baseline and 120 Minutes

• Systolic Blood Pressure

  At Baseline, 12 minutes, and 120 minutes

• Diastolic Blood Pressure

  At Baseline, 12 minutes, and 120 minutes

• Heart Rate

  At Baseline, 12 minutes, and 120 minutes

• Oxygen Saturation

  At Baseline, 12 minutes, and 120 minutes

Study Arms (3)

Kovacaine Mist High Dose

EXPERIMENTAL

400uL of Kovacaine Mist, as 2 sprays of 200uL.

Drug: 400uL of Kovacaine Mist

Kovacaine Mist Mid Dose

EXPERIMENTAL

200uL of Kovacaine Mist, as 2 sprays of 100uL.

Drug: 200uL of Kovacaine Mist

Kovacaine Mist Low Dose

EXPERIMENTAL

120uL of Kovacaine Mist, as 2 sprays of 60uL.

Drug: 120uL of Kovacaine Mist

Interventions

400uL of Kovacaine Mist DRUG

2 unilateral intranasal sprays of 200uL each.

Also known as: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Kovacaine Mist High Dose

200uL of Kovacaine Mist DRUG

2 unilateral intranasal sprays of 100uL each.

Also known as: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Kovacaine Mist Mid Dose

120uL of Kovacaine Mist DRUG

2 unilateral intranasal sprays of 60uL each.

Also known as: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Kovacaine Mist Low Dose

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female 3-17 years of age inclusive.
• Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.
• Normal lip, nose, eyelid, and cheek sensation.
• Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
• If age 8 and above, able to understand and provide informed assent.
• Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
• Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
• Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).

You may not qualify if:

• Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.
• History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
• History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
• Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
• Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
• Inadequately controlled thyroid disease of any type.
• Use of any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
• Frequent nose bleeds (≥ 5 per month).
• Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
• History of congenital or idiopathic methemoglobinemia.
• Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
• History of alcoholism and/or drug abuse.
• Pulpal pathology in the index tooth.
• Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.
• Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome.

Sponsors & Collaborators

• St. Renatus, LLC: lead
• Triligent International: collaborator
• Rho, Inc.: collaborator

Study Sites (1)

Big Grins

Fort Collins, Colorado, 80525, United States

Location

MeSH Terms

Interventions

Tetracaine

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Gregory D. Evans, DDS
• Organization: Big Grins Pediatric Dentistry

greg@biggrinswithdrgreg.com

970-407-1020

Study Officials

• Paul A. Moore, DMD/PhD/MPH

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (1)